Patient safety aims to minimize risk and prevent injury in healthcare. Despite rigorous standards, serious errors known as “never events” still occur. These incidents are a subset of medical errors considered entirely preventable, invariably resulting in death or serious physical or psychological harm to a patient.
The Official Definition of Never Events
The term “never event” was introduced in 2001 by Dr. Ken Kizer, former CEO of the National Quality Forum (NQF), to highlight intolerable medical mistakes. The NQF formalized the criteria for these incidents, officially referring to them as “Serious Reportable Events.” The designation requires the event to be unambiguous, meaning it must be clearly identifiable for reporting purposes. A second criterion is that the event must be serious, often resulting in death, disability, or loss of body function. Crucially, the event must be largely preventable through organizational policies and procedures. The NQF maintains and updates a list of these events, which now includes over two dozen specific incidents grouped into seven categories.
Specific Examples and Categories
The NQF categorizes never events to provide clear distinctions between different types of systemic failures within a healthcare setting.
Surgical or Procedural Events
Surgical or procedural events are the most recognized category of these errors. Examples include performing surgery on the wrong body part, on the wrong patient entirely, or performing the wrong surgical procedure on the correct patient. Another surgical event is the unintended retention of a foreign object, such as a sponge or surgical tool, inside a patient after the procedure is completed.
Product or Device Events
Product or device events involve patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility. This category also includes harm resulting from the use or malfunction of a device that is used or functions other than as intended. These events highlight failures in supply chain management and product sterilization protocols.
Patient Protection Events
Patient protection events focus on vulnerabilities of patients who cannot fully protect themselves due to their condition. Examples include patient suicide or self-harm that results in serious injury while the patient is under care in a healthcare setting. Another incident is the discharge or release of a patient who is unable to make decisions to an unauthorized person.
Care Management Events
Care management events focus on failures in the provision of treatment and patient monitoring. This category includes patient death or serious injury associated with a medication error, such as the wrong drug, dose, patient, or route of administration. This group also covers events like patient death or serious injury associated with the unsafe administration of blood products, such as a mismatched blood transfusion.
Financial and Regulatory Consequences
The designation of an incident as a never event carries significant regulatory and financial penalties for healthcare providers. The Centers for Medicare & Medicaid Services (CMS) has implemented a policy of non-reimbursement for care directly related to these events, shifting the financial burden away from the patient and federal payers. CMS requires hospitals to submit specific billing codes to identify these errors. This policy provides a strong financial incentive for healthcare organizations to invest heavily in prevention protocols and quality control measures. Furthermore, many states mandate the reporting of never events to public health agencies, increasing transparency and accountability.
Strategies for Prevention and Safety
Healthcare organizations employ process improvements and cultural shifts to reduce the occurrence of never events. A widely adopted strategy is the pre-operative “surgical time-out,” which requires the entire surgical team to pause and confirm the correct patient, site, and procedure before incision. This process serves as a final check against surgical errors. Following an adverse event or near-miss, a Root Cause Analysis (RCA) is performed to understand system failures and correct structural vulnerabilities. An overarching strategy is cultivating a “culture of safety,” which encourages staff to report errors and near-misses without fear of punitive action. Technology also plays a significant role, with solutions like barcoding for medication administration and electronic tracking systems helping to eliminate human-error-prone steps.